Kornimate/medical-research-clean huggingface dataset:
investigation of surgery, collagenase, and restorex for the improvement of peyronie's

Conditions: Peyronie's Disease

Summary: the purpose of this study is to compare key clinical outcomes of collagenase clostridium histolyticum injections versus surgery for the management of peyronie's disease.

after eligible patients have been informed about the study protocol and risks and consent have been given, men will be randomly assigned into either the collagenase clostridium histolyticum + penile traction therapy (cch + ptt) group or to the surgery + penile traction therapy (surgery + ptt) group. those in the cch + ptt group will receive the full 4 series of 8 xiaflex injections with 1-3 days between each set of 2 injections and 6 weeks prior to the next series. patients would then use the restorex traction device throughout the series to 3 months post-treatment. those that were assigned the surgery + ptt treatment protocol would undergo surgery using either penile plication or incision and grafting, depending on the degree of curvature and erectile function. traction using restorex will also be prescribed to these men 2-4 weeks post-operatively until 3 months post-treatment. key clinical outcomes of both treatment protocols will be compared.

Eligibility criteria:
inclusion criteria: * men with pd * \>18 years old * curvature ≥30 degrees * ability to achieve an erection satisfactory for intercourse with or without pde5 inhibitors exclusion criteria: * prior treatment with cch or surgery * moderate (shadowing) or severe (\>1 cm) penile calcification * any contraindications to cch, ptt, or surgery - as determined by the pi

Keywords: collagenase clostridium histolyticum restorex plication incision and grafting surgery
a study of avastin (bevacizumab) in combination with platinum-containing chemotherapy in patients with advanced or recurrent non-squamous cell lung cancer.

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this single arm study will assess the safety and efficacy of avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (nsclc). avastin will be given as first-line treatment in combination with platinum-based chemotherapy or in combination with any standard of care nsclc first-line chemotherapy used in line with the licensed national prescribing information. eligible patients will receive avastin (15mg/kg iv on day 1 of each 3 week cycle) concomitantly with chemotherapy. avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 500+ individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * histologically or cytologically documented inoperable, locally advanced ( stage iii), metastatic (stage iv) or recurrent nsclc other than squamous cell (tumors of mixed histology should be categorized by the predominant cell type); * ecog ps status 0-2; * life expectancy \>= 12weeks; * adequate renal, liver and hematological function. exclusion criteria: * mixed, non-small and small cell tumors, or mixed adenosquamous carcinomas with a predominant squamous component; * hemoptysis (\>=1/2 teaspoon of bright red blood) in previous 3 months; * evidence of tumor invading major blood vessels on imaging; * evidence of cns metastases, even if previously treated. * major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment, or anticipation of need for major surgery during study treatment; * prior chemotherapy for stage iiib/iv disease.
uti reference standard: delphi method

Conditions: Urinary Tract Infections

Summary: this study is set up by an international core group consisting of infectious disease specialists, geriatricians, urologists, microbiologists, emergency physicians and primary care physicians to develop a consensus-based research definition of urinary tract infections. the absence of such a reference standard leads to misclassification bias and heterogeneity between studies making progress in the field of uti difficult, for example with much needed near patient diagnostic tests.


Eligibility criteria:
inclusion criteria: * medical specialist working in the following fields: infectious diseases, urology, geriatric medicine, acute/emergency medicine, intensive care medicine, microbiology, and primary care * clinical and/or research experience with urinary tract infections exclusion criteria: * residency not completed yet * working in a different field than described above
gemigliptin and biomarkers of kidney injury and vascular calcification

Conditions: Diabetic Nephropathies

Summary: dipeptidyl peptidase-4 (dpp-4) inhibitors improve glycemic control and contain pleiotropic actions on kidney injury, albuminuria and vascular inflammation especially in animal models. we plan to evaluate the efficacy of potent dpp4-inhibitors (gemigliptin) in response to these aspects in diabetic nephropathy patients.

this is a multi-center, prospective, randomized, placebo-controlled trial. a total of 201 participants were enrolled and randomly assigned to gemigliptin 50 mg daily and standard care of diabetes mellitus for 6 months. the changes of coronary calcium score (cac score), cardio-ankle vascular index (cavi), estimated glomerular filtration rate (gfr), markers of vascular calcification and markers of tubular renal injury were evaluated at baseline and 6 months.

Eligibility criteria:
inclusion criteria: * patients with ckd stage 1-3 (egfr 15-60 ml/min/1.73ml) * non-insulin dependent diabetes mellitus , blood glucose level 30-250 mg/dl * had clinical features compatible with diabetic nephropathy (urine micro albuminuria \> 30 g/g creatinine or has evidence of diabetic retinopathy exclusion criteria: * history of allergy to dpp4-inhibitor * concurrent infectious disease * inflammatory diseases * post kidney transplantation * receiving cinacalcet, bisphosphonate ,previously treated with dpp4-inhibitors and sodium-glucose cotransporter-2 inhibitor (sglt2-i).

Keywords: gemigliptin diabetic nephropathy acute kidney injury vascular calcification
long protocol and growth hormone in poor responders

Conditions: Infertility

Summary: the long down regulation protocol is widely used in the in vitro fertilization cycles, now it will be assessed regarding its efficacy, in poor responder females undergoing in vitro fertilization cycles, alone and after the addition of growth hormone.


Eligibility criteria:
inclusion criteria: * poor responder females are those who posses two out of these three criteria: * female age ≥40 years * females who have at least one previous cancelled ivf cycle * por according to afc ≤ 5 or low amh value. exclusion criteria: * females over 45 years * females with fsh more than 20 iu/l * females with previous ovarian surgery * females suffering from causes of infertility other than poor ovarian response * females refusing to be enrolled in the study

Keywords: infertility
comparison of graft quality and patient morbidity following palatal harvesting.

Conditions: Gingival Recession; Palate; Wound

Summary: the purpose of this study is to compare four different connective tissue graft harvesting technique in terms of graft quality and patient post-operative morbidity

the primary aim is to compare 4 different connective tissue graft harvesting techniques in terms of morbidity and in terms of quality of the graft. the secondary aim is to evaluate the outcome of gingival recessions treated with grafts obtained from different harvesting approaches, in terms of mean root coverage, complete root coverage, keratinized tissue gain, clinical attachment level gain and gingival thickness

Eligibility criteria:
inclusion criteria: * 18 years of age or greater, * patients with no reported systemic diseases, * healthy periodontium or demonstrating stable periodontal condition following conventional periodontal therapy, * full mouth plaque score (fmps) and full mouth bleeding score (fmbs) of \< 15%, * clinical indication for periodontal plastic surgery utilizing ctg to treat either a single or a maximum of two recession defects (miller class i, ii) around natural teeth * no history of previous palatal harvesting exclusion criteria: * pregnancy * systemic condition that generally precludes surgical therapy or that could influence the outcome of therapy (e.g. diabetes with hba1c \> 7%, inr \> 3 etc.) * non-compensated systemic disease * poor oral hygiene with full mouth plaque score (fmps) and full mouth bleeding score (fmbs) \> 20% at baseline * inadequate endodontic treatment or tooth mobility at the site of surgery * radiographic evidence of bone loss
myocardial fibrosis identification in patients with anthracycline-induced cardiotoxicity

Conditions: Cardiomyopathy Due to Drug

Summary: this is an interventional study for patients who had developed anthracycline-induced cardiotoxicity (aic) during or after anthracycline-containing therapy, referred to the cardioncology unit for heart failure treatment

the main aim of this interventional study is to evaluate biochemical and imaging markers of fibrosis in patients who had previously developed aic during or after anthracycline-containing therapy. anthracycline-induced cardiomyopathy (aic) is define as a reduction in left ventricular ejection fraction (lvef) \>10% units from baseline and below 50%, assessed by echocardiography, during or after anthracycline-containing therapy. all patients will undergo: * at time 0 * an echocardiogram with lvef evaluation (biplane method) * a single blood sample. * at time 1 - a cardiac magnetic resonance (rmc) with contrast agent (t1 mapping technique) (time 1 = within 72 hours from blood sample).

Eligibility criteria:
inclusion criteria: * patients who developed aic during or after anthracycline-containing therapy assessed by lvef valuation by echocardiography. exclusion criteria: * age \<18 years * contraindications to contrast medium magnetic resonance imaging
florida puerto rico atrial fibrillation stroke study (fliper-af)

Conditions: Atrial Fibrillation

Summary: in this study, fl-pr stroke registry will be used to determine novel data on disparities in stroke care and outcomes for patients with atrial fibrillation (af) in 'real life' hospital setting. investigators will evaluate clinical practice for af detection and treatment in stroke patients within large stroke hospital systems of care with multi-ethnic patient populations and thereby representative of the states of florida and puerto rico. the results of this study will be of critical importance for secondary stroke prevention by identifying gaps in stroke care for patients with af and by recognizing the needs for developing targeted interventions to reduce disparities in diverse populations of stroke patients with af and improve systems of care for all stroke patients with af.


Eligibility criteria:
inclusion criteria: * age is 18 and older * primary diagnosis of ischemic stroke * enrolled in the florida - puerto rico stroke registry exclusion criteria: * primary diagnosis of intracerebral hemorrhage * diagnosis of subarachnoid hemorrhage * stroke not otherwise specified * no stroke related diagnosis * admission for elective carotid intervention only

Keywords: disparities florida-puerto rico stroke registry
graded motor imagery and total knee arthroplasty

Conditions: Total Knee Arthroplasty

Summary: this study was planned to investigate the long-term effectiveness of the early application of graded motor imagery therapy on pain parameters, functional performance, motor imagery skill, and kinesiophobia in individuals who underwent total knee arthroplasty surgery after knee osteoarthritis.

participants aged 45-80 who are scheduled for total knee arthroplasty surgery after knee osteoarthritis will be included. participants will be selected from the relevant population using a nonprobability random sampling method. participants who agree to participate in the study and meet the inclusion criteria will be assigned to one of the groups (conventional rehabilitation-only or conventional rehabilitation with graded motor imagery) using the closed envelope method. evaluations will be made one day before surgery, 6 weeks and 6 months after surgery for each group. pain visual analog scale; pressure pain threshold algometer; central sensitization central sensitization inventory; the joint range of motion goniometer; muscle strength handheld dynamometer; kinesiophobia tampa kinesiophobia scale; functional mobility and mental stopwatch timed get up and go test; choice task recognise™ application; motor imagery skill movement imagery questionnaire-3; functional assessment western ontario and mcmaster universities osteoarthritis index (womac); the catastrophic degree of pain is planned to be evaluated with the pain catastrophizing scale.

Eligibility criteria:
inclusion criteria: * diagnosed with knee osteoarthritis and being on the waiting list to receive unilateral total knee arthroplasty * approved by the orthopedist for early physiotherapy treatment after total knee arthroplasty exclusion criteria: * - individuals undergoing revision total knee arthroplasty or undergoing bilateral total knee arthroplasty, * contralateral knee osteoarthritis (defined by activity greater than 4/10 pain) * having undergone any physical therapy intervention or other surgery in the last 6 months * any neurological, cardiac, pulmonary or psychiatric disease (eg, uncontrolled diabetes mellitus, neoplasms, uncontrolled blood pressure, neurological conditions) before or after surgery; * fracture, infection in the acute postoperative phase or presence of fever * cognitive impairments that alter the probability of correct understanding of the motor imagery program * body mass index \> 35 kg / m2 * difficulties with understanding or communication * insufficient knowledge of turkish to follow the study instructions.

Keywords: graded motor imagery pain rehabilitation total knee arthroplasty
pharmacokinetic and safety study of ceftolozane/tazobactam in pediatric participants receiving antibiotic therapy for proven or suspected gram-negative infection or for peri-operative prophylaxis (mk-7625a-010)

Conditions: Proven or Suspected Gram-negative Bacterial Infection; Peri-operative Prophylaxis

Summary: the purpose of this study was to assess the pharmacokinetics, safety, and tolerability of a single intravenous dose of ceftolozane/tazobactam (mk-7625a) in pediatric participants. in each of the 6 age cohorts, an interim analysis of pharmacokinetics (pk) and safety data was conducted after approximately 3 participants had received the initially proposed dose. the interim analysis was to determine whether the initial dose was appropriate based on pre-defined criteria. if data from the interim analysis demonstrated that the initially proposed dose met the above criteria, enrollment was to continue with the same dose administered to approximately 3 additional participants of the same age range. however, if the interim analysis demonstrated that a new optimized dose was required, the new dose was to be administered to approximately 3 additional participants of the same age range.


Eligibility criteria:
key inclusion criteria: 1. males or non-pregnant females from birth to \<18 years of age 2. receiving standard of care antibiotic therapy for suspected or diagnosed gram-negative infection or for peri-operative prophylaxis 3. groups 1-4: calculated creatinine clearance rate (clcr) ≥ 80 ml/min/1.73m2 at baseline 4. group 5: clcr ≥ 50 ml/min/1.73m2 at baseline 5. group 6: clcr ≥ 20 ml/min/1.73m2 at baseline key exclusion criteria: 1. known allergy/hypersensitivity to any β-lactam antibacterial 2. history of clinically significant renal, hepatic, or hemodynamic instability 3. planned use of cardiopulmonary bypass or dialysis 4. planned blood transfusion within 24 hours of study drug administration 5. clinically significant abnormal laboratory test results not related to the underlying infection 6. receipt of piperacillin/tazobactam within 24 hours of study drug administration 7. likely to be at risk of hemodynamic disturbance following collection of the required pk blood samples
intravenous pentamidine for pneumocystis jirovecii pneumonia

Conditions: Hematologic Malignancy

Summary: the main objective of this study is to assess the safety of administering intravenous (iv) pentamidine for pneumocystis jirovecii pneumonia (pjp) prophylaxis in adult inpatients with hematologic malignancies and stem cell transplant recipients. there will also be an assessment of patient satisfaction associated with intravenous pentamidine pjp prophylactic therapy.

this study is a prospective, single arm study to assess safety of iv pentamidine for pjp prophylaxis. patient satisfaction associated with iv pentamidine will also be assessed using a survey adapted from the validated treatment satisfaction questionnaire for medication (version 1.4). adult patients with a hematologic malignancy or who are receiving or have received a stem-cell transplant at the university of illinois hospitals and clinics who have an indication for pjp prophylaxis therapy. they will receive intravenous pentamidine during their planned admissions for chemotherapy when they have an indication for and/or are due to receive pentamidine prophylaxis. these patients are outlined below in the inclusion criteria. patients may or may not have received aerosolized or iv pentamidine prior to inclusion in the study. eligible patients will receive iv pentamidine during hospital admissions. patients will be routinely monitored by nursing staff during and after the infusion. nursing staff will monitor the systolic and diastolic blood pressure at baseline and one hour post infusion. patients will also be monitored for nausea/vomiting. patients who receive iv pentamidine will have anti-emetics available on call to use in the event that they become nauseous. data will be collected on the type, grade, and incidence of adverse effects by research personnel.

Eligibility criteria:
inclusion criteria: * adults (18 years or older) * hematologic malignancy diagnosis or stem-cell transplant recipient * eligible for pjp prophylaxis therapy at time of enrollment as per institutional guidelines in compliance with nccn guidelines. these patients include: * acute myeloid leukemia patients receiving induction and consolidation (first line and relapsed/refractory) * acute lymphoid leukemia patients receiving hypercvad/r (cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, cytarabine, rituximab) * lymphoma patients receiving ice (ifosfamide, carboplatin, etoposide), da-r-epoch (dose-adjusted rituximab, etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin), and other inpatient lymphoma regimens * patients receiving other inpatient chemotherapy regimens that are given on a monthly basis * patients who have received an allogeneic stem cell transplant * have given informed consent * may have previously received inhaled or iv pentamidine exclusion criteria: * pregnancy * prisoners * patients with a documented allergy or hypersensitivity to pentamidine.
vascular disease--structure/function

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease

Summary: to investigate the relationship of non-invasively measured flow-mediated brachial artery dilation with coronary artery disease (cad).

background: this study meshed with a longitudinal case-control study, hl-35333, carotid atherosclerosis follow-up study. hl-35333 comprised 280 individuals older than 45 equally divided between men and women, half with and half without cad evaluated for risk factors at baseline and with completed follow-up with yearly b-mode for three years. the carotid atherosclerosis follow-up study quantified the interassociations of angiographically defined coronary artery disease and cad risk factors with progression. the nih funded a continuation of this effort to review existing ultrasound tapes from this study in order to additionally evaluate the associations of all these factors with extracranial carotid arterial dimensions (ecad: interadventitial and lumen diameters) and change in ecad over time. design narrative: the study assessed brachial artery reactivity among 100 cad subjects and 100 controls who had been previously enrolled in a study of the relationship between extracranial intima media thickness (ecimt) as assessed by b mode ultrasonographic measurements and cad status. most subjects had three consecutive b mode measurements at 12 month intervals. these subjects had brachial artery reactivity measurements according to a standardized protocol. linear regression analysis was used to relate brachial artery reactivity to cad status, gender and risk factors as predictors. interaction effects were also assessed between cad status and other risk factors and also between gender and other risk factors. similar analyses were performed to relate percent dilation to ecimt measurements. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
volumetric analysis of root resorption with mini-screw implant anchorage-assisted retraction of maxillary incisors

Conditions: Dental Dysgnathia

Summary: the intended study is designed as a prospective randomized controlled trial (rct), comparing and contrasting the effect of mini-screw implant anchorage-assisted versus regular maximum anchorage by retracting the maxillary incisors.

the objective of the clinical study proposal will be to investigate the performance of early root resorption in order to find out if the magnitude and direction of retraction is appropriate for the retraction of maxillary incisors following the mini-screw anchorage. therefore, the study will compare and contrast the efficacy and results of the volumetric measurement by cbct. patients males or females whose diagnoses require implant anchorage treatment will be included in the study. inclusion criteria for the study are as followings: orthodontic indication for skeletal anchorage adequate bone quantity for a palatal implant in the cbct good oral hygiene and normal wound healing capacity

Eligibility criteria:
inclusion criteria: * orthodontic indication for skeletal anchorage * adequate bone quantity for a palatal implant in the cbct * good oral hygiene and normal wound healing capacity exclusion criteria: * patients with cheilognathopalatoschisis and other system syndromes associated with craniofacial anomalies * patients with immunodeficiency, diseases requiring a prolonged steroid usage, previous radiation therapy or chemotherapy * patients with metabolic bone diseases or uncontrolled endocrine disorders * alcohol or drug abuse * pregnancy

Keywords: mini-screw implant anchorage retraction of maxillary incisors